RadiaBlock: Package Insert and Label Information

RADIABLOCK- oxybenzone and octinoxate lipstick
Medline Industries, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Oxybenzone 3%

Padimate O 7%

Purpose

Sunscreen

Sunscreen

Uses

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reaaply at least every 2 hours

Children under 6 months: Ask a doctor

Principal Display Panel

SPF 15 Lip Balm

NDC 53329-094-83

Carrington

RadiaBlock

Sunscreen SPF 15

Net Wt: .015 oz/4.2g

C:\Documents and Settings\gateway1\Desktop\53329-094 -- Medline -- RadiaBlock Lip Sunscreen Principal Display Panel
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RADIABLOCK
oxybenzone, octinoxate lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-094
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBENZONE (OXYBENZONE) OXYBENZONE 30 mg in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
COCOA BUTTER
.ALPHA.-TOCOPHEROL
CORN OIL
VITAMIN A PALMITATE
ALOE VERA LEAF
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
CARNAUBA WAX
MINERAL OIL
PARAFFIN
PETROLATUM
PROPYL GALLATE
JOJOBA OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53329-094-83 4.2 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/01/2013
Labeler — Medline Industries, Inc. (025460908)
Establishment
Name Address ID/FEI Operations
Bentley Laboratories, LLC 068351753 manufacture (53329-094)

Revised: 12/2017 Medline Industries, Inc.

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